BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD DUODOPA CASSETTE

    MDR report key: 23623746 · Received November 21, 2025

    Report

    Report Number
    3012307300-2025-12804
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586044175
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS PROVIDED; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CADD CASSETTE 100 ML, LN 68-2230-28 AND UNKNOWN LOT NUMBER. IT WAS STATED THAT THE NURSE REPORTED THAT THE PATIENT FELL OVER THE WEEKEND. MEDICATION LEAKED FROM THE CASSETTE DURING THE NIGHT, DAMAGING THE PUMP WHICH NOW DISPLAYS ERROR MESSAGE 1618. THE PUMP CAN NO LONGER BE STARTED. THEY REQUESTED A REPLACEMENT. THE NURSE WILL SEND THEM THE CURRENT DOSAGE. THE PATIENT IS ON SUBSTITUTE MEDICATION. CURRENT DOSAGES ARE MD OF 5.0 ML, KRT OF 3.5 ML PER HOUR, KRN OF 1.0 ML PER HOUR, AND ED OF 4.0 ML. THE PUMP WAS RUNNING AND WAS CONNECTED TO THE PATIENT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022613 CADD DUODOPA CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. UNKNOWN 10610586044175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown